A Phase II Study of ARX788 in People with Metastatic Breast Cancer

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Full Title

A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients Whose Disease is Resistant or Refractory to T-DM1, and/or T-DXd, and/or Tucatinib-containing Regimens

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug ARX788 in people with metastatic breast cancer that is positive for the HER2 protein and resistant to other medications that target HER2. ARX788 is designed to bind to HER2 on cancer cells, and then attack and kill them.

ARX788 is an “antibody-drug conjugate.” It is made up of an antibody and a chemotherapy drug. The antibody part of ARX788 binds to HER2 on cancer cells, and then the chemotherapy enters the cells and causes them to die. ARX788 is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants in this study must have metastatic HER2-positive breast cancer that continues to grow despite treatment that included T-DM1, and/or T-DXd, and/or tucatinib.
  • The serious side effects of prior therapies must go away before ARX788 is given.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Joshua Drago at 646-888-6971.

Protocol

22-161

Phase

II

Investigator

Co-Investigators

Diseases